BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 13011139 · Received December 15, 2021

    Report

    Report Number
    9612164-2021-04873
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    April 24, 2021
    Report Date
    December 15, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; IMPACT OF INSTRUCTIONS FOR USE ANDENDOLEAKS ON LONG-TERM MORTALITY AFTER TREATMENT FOR ABDOMINAL AORTIC ANEURYSM HIROSHI SATO, JOJI FUKADA, AND YUKIHIKO TAMIYA, ANNALS OF VASCULAR SURGERY; ANN VASC SURG 2021; 76: 309¿317. HTTPS://DOI.ORG/10.1016/J.AVSG.2021.03.047. MEAN AGE, MEAN GENDER, EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ENDURANT STENT GRAFTS WERE IMPLANTED DURING OPEN AND EVAR OF AAA ON UNKNOWN DATES. SOME PATIENTS WERE TREATED OUTSIDE THE IFU. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: TYPE I ENDOLEAK, TYPE III ENDOLEAK, TYPE II ENDOLEAK. THE CAUSE OF THE ADVERSE EVENTS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905414 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male